UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024058 |
|---|---|
| Receipt number | R000027516 |
| Scientific Title | Comparison between new laser endscopic imaging and histological imaging in gastric cancer |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2017/09/15 11:41:41 |
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Basic information
Public title
Comparison between new laser endscopic imaging and histological imaging in gastric cancer
Acronym
Comparison between new laser endscopic imaging and histological imaging in gastric cancer
Scientific Title
Comparison between new laser endscopic imaging and histological imaging in gastric cancer
Scientific Title:Acronym
Comparison between new laser endscopic imaging and histological imaging in gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare magnifying endoscopy with Blue Laser Imaging (ME-BLI) endoscopic image and histrogical findings of endoscopic submucosal dissection (ESD) specimen using the cases that were carried out ESD for the early gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the diagnostic performance of demarcation line of cancer and non-cancerous part from the comparison of ME- BLI image and histopathological image.
Key secondary outcomes
To consider the differences in the findings of ME-BLI and ME-NBI histopathologically.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases with early gastric cancer that underwent ESD at the Hospital of Kyoto Prefectural University of Medicine thereafter January 2011. In this cases that have enough ME-BLI images and histopathological images.
Key exclusion criteria
Cases that not underwent ME-BLI.
Cases that underwent ME-BLI but with inadequate images.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
465,Kajii-cho,Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
+81-75-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
465,Kajii-cho,Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
+81-75-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to evaluate between BLI and histological findings compared with NBI findings.
Management information
Registered date
| 2016 | Year | 09 | Month | 14 | Day |
Last modified on
| 2017 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027516
